<p>As antimicrobial resistance (AMR) intensifies and antibiotic innovation stalls, phage therapy is gaining renewed interest. However, its development is hindered by regulatory, scientific, and economic frameworks that are tailored to the standardised production of chemical drugs. This article examines two non-commercial models of phage therapy in Europe that challenge the mainstream pharmaceutical development paradigm. Based on in-depth interviews (22), as well as analysis of relevant regulatory and scientific materials, we compare the magistral phage model developed at the Queen Astrid Military Hospital in Belgium with the GMP-certified API model of the Hospices Civils de Lyon in France. Both initiatives mobilise public health facilities to produce and deliver phage therapies outside the marketing authorisation pathway. While their regulatory strategies differ, both resist commodification and highlight the role of public institutions in therapeutic innovation. However, they both face similar challenges, such as financial sustainability and regulatory alignment. We propose that hospital-based phage therapy not only serves as an effective last resort treatment option, but also offers a conceptual and institutional blueprint for re-evaluating drugs as a public good. These cases illustrate how public infrastructures can support more equitable, ecologically responsible forms of innovation in a context of global health crisis and therapeutic scarcity.</p>

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Taking medicines out of the market: public hospital-based phage therapy in Belgium and France

  • Koichi Kameda,
  • Charlotte Brives

摘要

As antimicrobial resistance (AMR) intensifies and antibiotic innovation stalls, phage therapy is gaining renewed interest. However, its development is hindered by regulatory, scientific, and economic frameworks that are tailored to the standardised production of chemical drugs. This article examines two non-commercial models of phage therapy in Europe that challenge the mainstream pharmaceutical development paradigm. Based on in-depth interviews (22), as well as analysis of relevant regulatory and scientific materials, we compare the magistral phage model developed at the Queen Astrid Military Hospital in Belgium with the GMP-certified API model of the Hospices Civils de Lyon in France. Both initiatives mobilise public health facilities to produce and deliver phage therapies outside the marketing authorisation pathway. While their regulatory strategies differ, both resist commodification and highlight the role of public institutions in therapeutic innovation. However, they both face similar challenges, such as financial sustainability and regulatory alignment. We propose that hospital-based phage therapy not only serves as an effective last resort treatment option, but also offers a conceptual and institutional blueprint for re-evaluating drugs as a public good. These cases illustrate how public infrastructures can support more equitable, ecologically responsible forms of innovation in a context of global health crisis and therapeutic scarcity.